Therapeutic Fasting and Immune Aging
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentre Hospitalier Universitaire de Saint Etienne
About this trial
Immunosenescence is the age-related decline of the immune system, involving a state of chronic inflammation and a decrease in the diversity/adaptability of the lymphocyte repertoire. The consequences of immunosenescence are multiple, including increased susceptibility to infections and poorer vaccine responses.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient affiliated or entitled to a social security scheme
Residing in a Long-Term Care Unit (LTCU) or a Facility for the Elderly Dependent (EHPAD)
A person deemed a priori, by the geriatrician member of the monitoring committee, to be capable of following the dietary recommendations required for the study.
A person deemed a priori, by the clinician in charge, to be able to follow the dietary recommendations required by the study.
Disqualifiers
Inability and/or unwillingness to follow dietary recommendations and/or perform follow-up examinations required for the study
Iso-resource group 1 or 2 according to the AGGIR grid
BMI < 18.5 kg/m2 or recent weight loss > 5% in 1 month or recent weight loss > 10% in 6 months from previous weight
Albuminemia < 30g/l
Trial design
Design model
Single group
Treatments tested in this trial
Fasting mimicking diet (FMD)
Dietary supplementD1 will correspond to a "pre-fasting" phase, with about 800 kcal of intake (approximately 40% of normal caloric intake) from a mono-nutrient diet (fruit, rice or potato according to the patient's preferences). Then D2 and D3 will correspond to the days of actual fasting, with 200-350 kcal of intake (10-18% of normal caloric intake) in the form of 100 ml of broth or vegetable juice (with a teaspoon of linseed oil) three times a day, and vaccination will take place on D4, after returning to a normal diet. 2 to 3 liter of water or unsweetened drink per day is required.Laxatives (unsweetened) will be prescribed and can be taken as during the fasting period.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Fasting mimicking diet (FMD)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
rate of premature discontinuation of the fasting-mimicking diet
measurement of the rate of occurrence of a clinical event considered to require discontinuation of the fasting diet : The occurrence of a clinical event considered to require discontinuation of the fasting diet will be defined as the presence between D14 and D21 of at least one of the following conditions: * Weight loss \> 5%, * Hypoglycemia \< 0.5 g/l (\< 2.8 mmol/l), * Hypothermia \< 35°C, * Heart rate \< 50 beats per minute, checked twice at 15 minute intervals, * Low systolic blood pressure \< 90 mmHg or \> 200 mmHg; or diastolic blood pressure \< 60 mmHg or \> 110 mmHg; or mean blood pressure \< 70 mmHg, checked twice at 15-minute intervals, * Increase of 5 points on the visual analog pain scale between D14 and D21, * A score of 1 on the EVIBE visual analog scale (instantaneous assessment of well-being) between D14 and D21, * Any serious acute clinical event (fall with serious traumatic consequence, acute medical or surgical condition).
Time frame
between Day 14 and Day 21Secondary outcomes
1
serious and non-serious adverse events reported
Comparison of the nature and frequency of serious and non-serious adverse events reported from D0 to D13 (pre fasting diet phase), D14 to D16 (fasting diet phase) and D17 to D42 (post fasting diet phase)
Time frame
Between day 0 to day 422
composite outcome: evolution of biological biochemic parameters
Evolution of measurements of blood glucose, ketones, albumin, prealbumin and IGF-1 Unit of measure : ng/ml
Time frame
Day 0 to Day 423
composite outcome: evolution of biological blood parameters
Evolution of the measurement of the blood total lymphocyte count (CD4, CD8, CD19, naive, effectors, memories, regulators, etc.). Unit of measure : %
Time frame
Day 0 to Day 424
composite outcome: evolution biological inflammatory parameters
Evolution of inflammatory markers (CRP, IL1, IL6, TNFalpha) Unit of measure : ng/ml
Time frame
Day 0 to Day 42Sponsors and contacts
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Source ClinicalTrials.gov
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